Health Canada Grants Priority Review to AbbVie's Investigational Regimen of Glecaprevir/Pibrentasvir

AbbVie has submitted a New Drug Submission (NDS), and received priority review from Health Canada, for its investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) for the treatment of all major chronic hepatitis C virus (HCV) genotypes.

If approved, G/P may provide a shorter treatment duration for genotypes 1-6 (GT1-6) in patients without cirrhosis, who make up a large portion of HCV patients in Canada, and an additional treatment option to patients with compensated cirrhosis (Child-Pugh A). G/P is also intended to address the unmet medical needs of patients with specific treatment challenges, including those with severe chronic kidney disease (CKD) and those not cured with previous direct acting antiviral (DAA) treatment.

"HCV patients with severe chronic kidney disease present a complex challenge for physicians to treat. This is particularly true in those with genotype 2 and 3 infection, and those with cirrhosis," said Dr. Curtis Cooper, Director of the Regional Hepatitis Program at the Ottawa Hospital. "Recent clinical trial results are a positive development in AbbVie's investigation of the G/P regimen for patients with chronic kidney disease, who currently have limited HCV treatment options."

"At no other time in history has the goal of eliminating hepatitis C in Canada been within reach like it is now, said Stéphane Lassignardie, General Manager, AbbVie Canada. "We are firmly committed to seeing this goal accomplished. As such, we have invested significantly in recent years in clinical trials in Canada for our investigational, pan-genotypic G/P regimen and will continue collaborating with Health Canada to help provide a cure for as many Canadians as possible living with HCV."

AbbVie's NDS is supported by data from eight registrational studies in AbbVie's G/P clinical development program, which evaluated more than 2,300 patients in 27 countries, including 174 patients in Canada, across all major HCV genotypes and special populations. Patient populations studied included GT1-6, those new and experienced to antiviral treatment, those with compensated cirrhosis and without cirrhosis, and patients with specific treatment challenges, including those with severe CKD, and those not cured with a prior DAA-containing regimen. The registrational program for G/P was designed to investigate a faster path to virologic cure* for all major HCV genotypes (GT1-6) and with the goal of addressing areas of continued unmet need.

On January 24, AbbVie announced its marketing authorization application (MAA) for G/P has been validated and is now under accelerated assessment by the European Medicines Agency (EMA). On December 19, 2016, AbbVie submitted its New Drug Application (NDA) for G/P to the U.S. Food and Drug Administration (FDA) for the treatment of GT1-6 chronic HCV. And on September 30, 2016, AbbVie announced that G/P was granted Breakthrough Therapy Designation by the FDA for genotype 1 patients not cured with prior direct-acting antivirals.

G/P is an investigational product and its safety and efficacy have not been established.